The Impact of Probiotics on Biomarkers and Symptom Severity in Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 252
- 试验地点
- 1
研究概览
简要总结
The goal of this double-blind parallel-arm randomized controlled trial is to learn if a probiotic supplement (containing a new strain derived from L. reuteri) alters outcomes related to symptom severity and transit time in adults with irritable bowel syndrome (IBS). The main question it aims to answer is:
Does the probiotic alter IBS symptom severity?
Researchers will compare the probiotic to a placebo (a lookalike substance that contains no probiotic) to see if the probiotic works to alter outcomes.
Participants will:
Be randomized to either take the probiotic supplement or placebo supplement daily for 12 weeks.
Visit the lab for 4 study visits (visit 1: screening and informed consent; visit 2: randomization, data collection, beginning the intervention; visit 3: end of intervention and data collection; visit 4: 3 month post intervention follow up and data collection).
Provide biological samples (blood, stool, saliva, urine) Complete questionnaires
详细描述
The BIO-IBS study is a double-blind, randomized, placebo-controlled clinical trial investigating whether a combination probiotic improves symptoms in adults with irritable bowel syndrome (IBS). The trial also explores biological mechanisms and predictors of treatment response.
Background & Rationale IBS is a common disorder of gut-brain interaction (~4% prevalence in Sweden). Current treatments include dietary, pharmacological, and psychological approaches. Increasing evidence suggests the gut microbiome plays a key role, prompting interest in probiotics.
Aims
1. Evaluate effect of probiotic combination on IBS symptoms. 2, Identify predictors of response. 3. Investigate IBS pathophysiology and biomarkers.
Study Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with IBS according to ROME V criteria
- •IBS-SSS greater than or equal to 75
- •Adult over 18 years old
- •BMI 18.5-35 kg/m2
- •Able to understand the participant information sheet and willing to comply with the study protocol
- •Able to give informed consent
- •Able to complete the Swedish questionnaires
排除标准
- •History of any gastroenterology disease including coeliac disease, heart, liver, neurological, or current psychiatric disease, diabetes, any surgery to the abdomen that affects intestinal function (not including cholecystectomy, appendectomy, ceasarean section).
- •The use of opioids 1 month prior to screening and throughout the study
- •The use of probiotic supplements from 14days before randomization and during the study (not including foods with probiotic components)
- •Consumption of antibiotics 3 months prior to screening and throughout the study
- •The start of any new drugs that affect the gastrointestinal tract or symptoms within the last month before the start of the study. As well as the start of new diets of psychological therapy as treatment for IBS symptoms.
- •Participation in any medical research during the last month
- •Clinically relevant lab abnormalities at the time of screening (fecal calprotectin greater than or equal to 150 ug/g as absolute cutoff. If calprotectin is between 50 - 150ug/g the decision is made on clinical judgement)
- •Pregnancy, plan to become pregnant during the study, breastfeeding
- •alcohol consumption >14 units per week
- •Use of recreational active drugs during 1 month before screening or during the study
- •Use of medication that primarily affects bowel function, transit time, stool consistency 2 weeks before the intervention or during the 12 week intervention period
研究组 & 干预措施
Control
Adults with IBS who have been randomized to receive the placebo
干预措施: Placebo Supplementation (Other)
Intervention
Adults with IBS who have been randomized to receive the intervention
干预措施: Probiotic Supplementation (Lactobacillus Reuteri) (Other)
结局指标
主要结局
未指定
次要结局
- Gastrointestinal Symptom Rating Scale- IBS (GSRS-IBS)(Screening (15-60 days pre-intervention), baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84), 3 month follow up post intervention)
- IBS-quality of life (IBS-QoL)(Baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84), 3 month follow up post intervention)
- Work Productivity and Activity Impairment:IBS (WPAI:IBS)(Baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84), 3 month follow up post intervention)
- Hospital Anxiety and Depression Scale (HADS)(Baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84), 3 month follow up post intervention)
- Patient Health Questionnaire (PHQ)(Baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84), 3 month follow up post intervention)
研究者
Magnus Simrén
Professor
Sahlgrenska University Hospital